Carotid AtherosclerosisPhase 1SMART-CNCT03871725
Sonodynamic Therapy in the Treatment of Carotid Atherosclerosis
A Phase 1 study testing Sonodynamic therapy (SDT) in people with Carotid Atherosclerosis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose of this study is to evaluate the safety and initial effectiveness of this technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Sonodynamic therapy (SDT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2019to 30 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 80 years
- Carotid artery with 30%~70% stenosis by ultrasound and plaque thickness>2.5mm
- Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
- Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP<140 and diastolic BP<90 under resting conditions) and diabetes(HbA1c<7%)
- Written informed consent
Who cannot join
- Non-atherosclerotic carotid artery stenosis
- Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
- Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit
- Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
- Previous significant adverse reaction to a statin
- Systemic disorders such as hepatic, renal, hematologic, and malignant disease
Show all 12Show fewer
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study
- Allergic to DVDMS or sonovue
- Diagnosis of porphyria
- Pregnant women and nursing mothers
- History of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy
- Patient who is attending other clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Official title: Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose of this study is to evaluate the safety and initial effectiveness of this technique.
Read the detailed description
Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial MR imaging of the carotid artery allowed observation of changes in plaque composition. Contrast enhanced ultrasound (CEUS) is a well accepted technique for detection of intraplaque neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage elimination and inhibit matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Sonodynamic therapy (SDT)
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonodynamic therapy (SDT)Combination product
Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%.
| Study group | Role | What they receive |
|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Receives: Combination Product: Sonodynamic therapy (SDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque MaxWT, as assessed by MRI
The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Secondary outcomes (8)
Change in IPH volume, as assessed by MRI
The changes in intraplaque hemorrhage (IPH) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Change in LRNC volume, as assessed by MRI
The changes in LRNC (lipid-rich necrotic core) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Change in plaque LM volume, as assessed by MRI
The changes in LM (loose matrix) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Change in calcification volume, as assessed by MRI
The changes in calcification (CA) volume as assessed by MRI.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Change in plaque volume, as assessed by MRI
The changes in plaque volume(mm3) as assessed by MRI
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Change in MVE, as assessed by CEUS
The changes in normalised maximal video-intensity enhancement (MVE) are calculated to quantify the density of IPN as assessed by CEUS.
Measured: Measured at Baseline, 1, 3, 6, and 9 months
MACCE
incidence of major adverse cardiovascular and cerebrovascular events(MACCE)
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Incidence of adverse events
Allergic to sunshine,hepatic or renal dysfunction,thyroid dysfunction
Measured: Measured at Baseline, 1, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start5 Jan 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Tian, First Affiliated Hospital of Harbin Medical University
- Investigators
- YE TIAN, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871725
- Sponsor's protocol ID
- SMART-C pilot
- Acronym
- SMART-C
- Status last verified
- Jul 2024
- First submitted
- 8 Mar 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
- ClinicalTrials.gov ID
- NCT03871725
- Acronym / sponsor ID
- SMART-C / SMART-C pilot
- Conditions
- Carotid Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The purpose of this study is to evaluate the safety and initial effectiveness of this technique.
Detailed description
Carotid atherosclerotic plaque is an important cause of ischemic stroke. Treatments for patients with carotid plaque include lifestyle changes, medical management(such as control of hyperlipidemia, hypertension, and diabetes) and carotid revascularization(carotid endarterectomy or carotid artery stenting). Studies have suggested that plaque morphology and composition are important determinants of plaque stability, using serial MR imaging of the carotid artery allowed observation of changes in plaque composition. Contrast enhanced ultrasound (CEUS) is a well accepted technique for detection of intraplaque neovascularization(IPN) in carotid atherosclerotic disease. The purpose of this trial is to evaluate the safety and initial effectiveness of SDT. The SDT can induce macrophage elimination and inhibit matrix degradation, which will promote plaque lipid depletion, inflammation level decrease and changes in other plaque tissue components, leading to plaque stabilization and reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonodynamic therapy(SDT) | Experimental | Combination Product: Sonodynamic therapy (SDT)Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18- 80 years
- Carotid artery with 30%~70% stenosis by ultrasound and plaque thickness>2.5mm
- Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
- Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP<140 and diastolic BP<90 under resting conditions) and diabetes(HbA1c<7%)
- Written informed consent
Key exclusion criteria (12 listed)
- Non-atherosclerotic carotid artery stenosis
- Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
- Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit
- Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
- Previous significant adverse reaction to a statin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonodynamic therapy (SDT)Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%. | Combination product | Sonodynamic therapy(SDT) |
Primary outcome
Change in plaque MaxWT, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
The changes in plaque MaxWT (maximum wall thickness) as assessed by MRI.
8 secondary outcomes
Change in IPH volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Change in LRNC volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Change in plaque LM volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Change in calcification volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Change in plaque volume, as assessed by MRI
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Change in MVE, as assessed by CEUS
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
MACCE
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Incidence of adverse events
Time frame: Measured at Baseline, 1, 3, 6, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YE TIAN study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sonodynamic therapy (SDT) in people with Carotid Atherosclerosis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque MaxWT, as assessed by MRI (time frame: Measured at Baseline, 1, 3, 6, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.